Matching-Adjusted Indirect Comparison of Crisaborole Ointment 2% vs. Topical Calcineurin Inhibitors in the Treatment of Patients with Mild-to-Moderate Atopic Dermatitis
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Introduction: Crisaborole topical ointment, 2%, is a nonsteroidal, topical anti-inflammatory phosphodiesterase-4 (PDE4) inhibitor that is approved for the treatment of mild-to-moderate atopic dermatitis (AD). The objective of the current analysis was to compare the efficacy of crisaborole 2% relative to pimecrolimus 1%, tacrolimus 0.03% and tacrolimus 0.1% in patients aged ≥ 2 years with mild-to-moderate AD by comparing improvement in Investigator’s Static Global Assessment scores ((ISGA scores of 0/1 indicating “clear or almost clear”). ISGA was selected as the primary efficacy outcome given the US Food and Drug Administration’s recommendations on the use of ISGA for assessment of global severity in AD and to align with efficacy measurements in the crisaborole registration trials. Safety endpoints could not be analyzed due to differences in outcome definitions across studies. Methods: Efficacy of crisaborole was evaluated using individual patient data (IPD) from two pivotal phase III randomized controlled trials (RCTs), and efficacy of comparators was evaluated using published RCTs included in a previous network meta-analysis. Vehicle controls were not comparable due to differences in ingredients and population imbalance and, therefore, an unanchored matching-adjusted indirect comparison (MAIC) was used, which reweighted IPD for crisaborole to estimate absolute response in comparator populations. Results: The odds of achieving an improvement in ISGA score was higher with crisaborole 2% versus pimecrolimus 1% (odds ratio [OR] 2.03; 95% confidence interval [CI] 1.45–2.85; effective sample size = 627, reduced from 1021; p value < 0.001) and for crisaborole 2% versus tacrolimus 0.03% (OR 1.50; 95% CI 1.09–2.05; effective sample size = 311, reduced from 1021; p = 0.012). Conclusion: The unanchored MAIC suggests that the odds of achieving an improvement in ISGA score is greater with crisaborole 2% than with pimecrolimus 1% or tacrolimus 0.03% in patients aged ≥ 2 years with mild-to-moderate AD. These results are consistent with findings from the previously published network meta-analysis, which used a different methodology for performing indirect treatment comparisons.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Dermatology and Therapy |
| Vol/bind | 12 |
| Udgave nummer | 1 |
| Sider (fra-til) | 185-194 |
| Antal sider | 10 |
| ISSN | 2193-8210 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
This study was sponsored by Pfizer Inc. Pfizer Inc. is also funding the journal’s Rapid Service fee.
Funding Information:
This study was sponsored by Pfizer Inc. Pfizer Inc. is also funding the journal’s Rapid Service fee. Editorial/medical writing support was provided by Katie Crosslin, PhD, and Holly Richendrfer, PhD at Evidera and was funded by Pfizer Inc. (New York, NY, USA). All named authors meet the International Committee of Medical Journal. Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole and have provided final approval of the version to be published. HT, VC, EK and JCC have made substantial contributions to the conception/design. HT, VC and EK have made substantial contributions to the data acquisition and analysis. All authors have made substantial contributions to the interpretation of data for the work, drafting of the work and critical revision of the article for important intellectual content. All authors have provided final approval of the manuscript. Some of the data in this manuscript have appeared in a poster presented at the International Society for Pharmacoeconomics and Outcomes Research 22nd Annual European Congress; 2–6 November 2019; Copenhagen, Denmark: Fahrbach K, Tarpey J, Bergrath E, et al. A systematic literature review and network meta-analysis (NMA) of crisaborole 2% ointment for the treatment of mild-to-moderate atopic dermatitis (AD). Value Health. 2019;22 (Suppl 3):S597–S598. Abstract PDG6. Howard Thom has received personal consulting fees from Pfizer Inc., Eisai Co. Ltd, Lundbeck, Argenx, Novartis Pharma AG, Roche Holding AG, Bayer AG, BMS and Janssen Pharmaceuticals. Vincent Cheng has received personal consulting fees from Pfizer Inc. and BMS. Edna Keeney has received personal consulting fees from BMS, Pfizer Inc. and Roche Holding AG. Amy Cha, Joseph C. Cappelleri, Maureen P. Neary and Chuanbo Zang are employed by Pfizer Inc. and own Pfizer stock and/or stock options. Anthony Eccleston is employed by Pfizer Ltd and owns Pfizer stock and/or stock options. Jacob P. Thyssen is an advisor/investigator or speaker for Pfizer Inc., AbbVie, Eli Lilly and Company, Almirall, LEO Pharma, Regeneron and Sanofi-Genzyme. Evidera received funding from Pfizer Inc. to develop this manuscript. This article is based on data from previously conducted studies and does not contain any studies with human participants or animals performed by any of the authors. Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual anonymized participant data. See http://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.
Publisher Copyright:
© 2021, The Author(s).
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